In the United States, medical device law is being dramatically reconfigured in response to rapidly evolving technology, as well as increasing budget and resource constraints within the Center for Devices and Radiological Health (CDRH). These changes affect small startup companies and large multinationals alike. Companies now need sophisticated and experienced guidance to navigate through the CDRH and resolve CDRH-related issues.
Within this new and complicated regulatory environment, our strategic assistance at the premarket stage focuses on avoiding costs and saving time. We assist with Section 510(k) premarket notifications, IDE submissions, PMA applications, humanitarian device exemption (HDE) submissions, panel reviews, scientific disputes and appeals, resolution of jurisdictional uncertainties, and device modification analyses.
At the postmarket stage, we help clients ensure that product marketing strategies are optimized, while compliance and other liability exposures are controlled. To maximize market potential, we provide creative promotional, reimbursement, marketing, and distribution strategies. We support day-to-day compliance activities by offering technical advice on such issues as medical device reporting, cGMPs, and recalls and field corrections. We also anticipate, and seek to contain, product liability exposure.
When enforcement concerns arise, we leverage our experience with some of the largest and most complex government investigations and settlements of the last decade. As the FDA, DOJ, Health Care Financing Administration (HCFA), and the HHS’s Office of Inspector General (OIG) continue to take an aggressive enforcement stance, we help clients respond to civil and criminal enforcement and compliance actions. These include:
- FDA Form 483 and warning letter responses
- Import/export issues
- Consent decree issues
- FDA integrity policy